Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bambino Gesù Hospital and Research Institute
• Treatments: alpha-Tocopherol; Choline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• persistently elevated serum aminotransferase levels

• diffusely echogenic liver on imaging studies suggestive of fatty liver

• biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

• hepatic virus infections (HCV RNA-PCR negative)

• Hepatitis A, B, C, D, E and G

• cytomegalovirus and Epstein-Barr virus

• alcohol consumption

• history of parenteral nutrition

• use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism

• autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria